Radiotherapy-Associated Atrial Fibrillation | NCT05927246

Studies
Radiotherapy-Associated Atrial Fibrillation

NCT05927246

Sponsor

Istanbul University

Status

Completed

Last Update Posted

Jul 3, 2023Actual

Enrollment

400Actual

Phase

Not provided

Conditions

Atrial Fibrillation New Onset

Interventions

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2023Actual

Primary Completion Date

Jun 1, 2023Actual

Completion Date

Jun 1, 2023Actual

First Submitted Date

Jun 23, 2023

First Submission Date that Met QC Criteria

Jun 29, 2023

First Posted Date

Jul 3, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 29, 2023

Last Update Posted Date

Jul 3, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Radiotherapy associated Atrial Fibrillation (RADAF) is an observational study to evaluate onset time and frequency of atrial fibrillation in patients with thoracic malignancies and breast cancer.

Each patient will have 12 lead ECG prior, and daily during radiotherapy.

Detailed Description

Collected data will be truly anonymised and individuals will no longer identifiable, and than evaluated for occurrence of atrial fibrillation.

Inclusing Criteria:

Patients with radiotherapy for thoracic malignancy or breast cancer
Between 18-99 years-old

Exclusion Criteria:

Patients with history of radiotherapy
Patients with history of atrial fibrillation
Patients with pacemaker implantation

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

400Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Patients with Thoracic Malignancies		All patients undergoing RT for Thoracic Malignancies	Diagnostic Test: ECG
Patients with Breast Cancer		All patients undergoing RT for Breast Cancer	Diagnostic Test: ECG

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ECG	Diagnostic Test	12 lead ecg for each participant	Patients with Breast Cancer Patients with Thoracic Malignancies

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Occurrence of atrial fibrillation	Occurrence of atrial fibrillation	1 day During radiotherapy
Onset time of atrial fibrillation	Onset time of atrial fibrillation	1 day During radiotherapy

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with radiotherapy for thoracic malignancy or breast cancer
Between 18-99 years-old

Exclusion Criteria:

Patients with history of radiotherapy
Patients with history of atrial fibrillation
Patients with pacemaker implantation

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

99 Years

Standard Ages

AdultOlder Adult

Study Population

Patients with breast and thoracic cancers will be evaluated for incidence and onset time of AFib.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Cafer Zorkun, MD PhD	Faculty member	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Istanbul Faculty of Medicine		Fatih	Istanbul	34093	Turkey (Türkiye)

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D001281	Atrial Fibrillation
D001943	Breast Neoplasms
D008175	Lung Neoplasms
D066126	Cardiotoxicity

Ancestor Terms

ID	Term
D001145	Arrhythmias, Cardiac
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D010335	Pathologic Processes

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D004562	Electrocardiography

Ancestor Terms

ID	Term
D006334	Heart Function Tests
D003935	Diagnostic Techniques, Cardiovascular
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis

Browse Leaves

Not provided

Browse Branches

Not provided